Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
The drawing objections of record have been withdrawn
The claim objections of record have been withdrawn
The 112 rejections of record have been withdrawn
Applicant’s arguments filed 10/01/2025, with respect to the rejection(s) of claim(s) 1 under 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made, see new rejection below.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the claims 4-5 ad 15-16 must show the varying length percentages in comparison with the stent, since the membrane is folded over the stent the length of the membrane is not as long as the claims describe, the claims could also be amended to recite “the unfolded length of the membrane is longer.” This feature must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because it includes reference numbers. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
The proper headings have not been utilized
Appropriate correction is required.
Claim Objections
Claim 1-17 objected to because of the following informalities:
Claim 1, 7, and 10 recites “being arranged on an inside/outside” but should recite “is arranged on an inside/outside”
Claims 1, 5, and 7-10 refer to “respective membrane ends,” and “respective ends,” limitation labels should be consistent
Claim 1 recites “respective end of a stent” but should recite “respective ends of the first or second stent.”
Claim 2 recites “a more inwardly arranged stents have” and “a more outwardly arranged stents” but should recite “a more inwardly arranged stent has” and “a more outwardly arranged stent”
Claims 7-10 repeats language of the independent claim but is already dependent on the independent claim, the claims should only further limit the existing subject matter of the independent claim.
Claim 8-9 recite the membrane but should recite “the at least one membrane”
Claim 13 recites that the retaining elements “is directed” but should recite that the retaining elements “are directed”
Claim 17 recites “of the first stent and the second stent” but should recite “of the first stent and/or the second stent”
Claims 2-16 recite “A multiple stent device” but should recite “The multiple stent device”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-6, 14, and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites “a nominal diameter” The broad and indefinite scope of the limitation “nominal” fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite.
Claim 2 recites “preferably having a larger nominal diameter” The broad and indefinite scope of the limitation “preferably” fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite.
Claim 3 recites “the at least one membrane includes a tube. It is unclear what is meant by “includes a tube,” the specification does not further add clarity.
Claim 3-6 recite “at least one membrane” but it is unclear if the first or second membrane is being referred to, the language could be replaced with “the first or second membrane.”
Claim 6 recites “may be made” but this language is unclear, and object “may be made” from any material, the claim language should recite “are made”
Claim 14 recites “individual stent sections” The broad and indefinite scope of the limitation “stent sections” fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite.
Claim 17 recites “folded around respective ends of the first and second stent” but should recite “folded around respective ends of the first or second stent.” It is unclear if the ends of each membrane are folded round both the stents at the same time or just a single stent.
Dependent claims are likewise rejected.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1, 3, 4, 6, 9, 11, 12, and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over by Bynon (WO 9633672 A1) in view of Amplatz (US 20090210048 A1).
Regarding claim 1, Bynon teaches a multiple stent device (abstract) comprising at least two coaxially arranged stents (element 18 and 20. Fig 5) and at least one membrane (element 16, fig 5), wherein a first stent (element 18) being arranged on an inside (element 18) and a second stent (element 20) being arranged on an outside (element 20), characterized in that a first membrane is arranged on the inside of the first stent and/or a second membrane is arranged on the outside of the second stent (element 16 in fig 5 is on the outside of stent 20), wherein the respective membrane ends (pg 16-17, fig 5 description, the longer end) are folded around the respective ends of a stent on which they are arranged (pg 16-17, fig 5 description).
Bynon does not exactly teach the folding direction as claimed. Amplatz teaches a covered stent device ([0042]) wherein a membrane is folded towards an inside of a stent ([0042]). Modifying the in-to-out folding direction with the out-to-in folding direction teaches a stent wherein membrane is arranged on the outside of the second stent and wherein respective membrane ends are folded around respective ends of a stent on which they are arranged, in such a way that the respective membrane ends are guided between the first and the second stent (membrane 16 in figure 5 would be placed on the outside of stent 20 and folded to the inside of stent 20, the ends would be between stent 20 and 18).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Bynon by changing the folding direction from folding from inside to outside to instead by folding from outside to inside, as taught by Amplatz, because it would prevent a fold getting caught on the vessel wall ([0042]).
Regarding claim 3, Bynon further teaches that the at least one membrane (element 16) includes a tube (view fig 2-5, the membrane is on a tubular structure and includes a tube).
Regarding claim 4, Bynon further teaches that the at least one membrane is 5 to 25% longer than the stent (the membrane must be 0-100% longer than the stent to fold over the way that it does, also see claim 7, each end is up to ½ the length of the stent making the total range between 0-100% longer, which encompasses 5-25).
Regarding claim 6, Bynon further teaches wherein the at least one membrane may be made of a film or knitted, woven or sewn from a thread (see field of invention, element 16 made from flexible material PTFE, PFTE is made from weaving/sewing/knitting).
Regarding claim 9, Bynon further teaches comprising two coaxially arranged stents (element 18 and 20. Fig 5) and one membrane (element 16), wherein the first stent (element 18) is positioned on the inside (element 18) and the second stent (element 20) is positioned on the outside (element 20), characterized in that the membrane (element 16, fig 5) is arranged on the outside of the second stent (element 16 in fig 5 is on the outside of stent 20).
Bynon does not exactly teach the folding direction as claimed. Amplatz teaches a covered stent device ([0042]) wherein a membrane is folded towards an inside of a stent ([0042]). Modifying the in-to-out folding direction with the out-to-in folding direction teaches a stent wherein the membrane ends are folded over onto the inside of the second stent so that the membrane is are clamped in place between the (membrane 16 in figure 5 would be placed on the outside of stent 20 and folded to the inside of stent 20, the ends would be between stent 20 and 18).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Bynon by changing the folding direction from folding from inside to outside to instead by folding from outside to inside, as taught by Amplatz, because it would prevent a fold getting caught on the vessel wall ([0042]).
Regarding claim 11, Bynon further teaches wherein retaining elements (element 21, fig 1) are positioned at least at one end of a stent of the multiple stent (element 21, fig 1).
Regarding claim 12, Bynon further teaches wherein the retaining elements (element 21, fig 1) are an extension of at least one end portion of at least one stent of the multiple stent device (element 21, fig 1).
Regarding claim 14, Bynon further teaches that at least one stent of the multiple stent (element 18 or 20) comprises a plurality of individual stent sections (stent has sections, see figures).
Regarding claim 15, Bynon further teaches that the at least one membrane is 25 to 50% longer than the stent (the membrane must be 0-100% longer than the stent to fold over the way that it does, also see claim 7, each end is up to ½ the length of the stent making the total range between 0-100% longer, which encompasses 25-50).
Regarding claim 16, Bynon further teaches that the at least one membrane is 75 to 100% longer than the stent (the membrane must be 0-100% longer than the stent to fold over the way that it does, also see claim 7, each end is up to ½ the length of the stent making the total range between 0-100% longer, which encompasses 75-100).
Regarding claim 17, Bynon teaches a multiple stent device (abstract) comprising at least two coaxially arranged stents (element 18 and 20. Fig 5) including a first stent (element 18) disposed radially inward (element 18) and a second stent (element 20) disposed radially outward (element 20), and at least one membrane (element 16) characterized in that a first membrane is arranged on inner lumen facing side of the first stent and/or a second membrane (element 16, fig 5) is arranged on the outer vessel facing wall of the second stent (element 16 in fig 5 is on the outside of stent 20), wherein the respective membrane ends (pg 16-17, fig 5 description, the longer end) are folded around the respective ends of a stent on which they are arranged (pg 16-17, fig 5 description).
Bynon does not exactly teach the folding direction as claimed. Amplatz teaches a covered stent device ([0042]) wherein a membrane is folded towards an inside of a stent ([0042]). Modifying the in-to-out folding direction with the out-to-in folding direction teaches a stent wherein membrane is arranged on the outside of the second stent and wherein respective membrane ends are folded around respective ends of a stent on which they are arranged, in such a way that the respective membrane ends are guided between the first and the second stent (membrane 16 in figure 5 would be placed on the outside of stent 20 and folded to the inside of stent 20, the ends would be between stent 20 and 18).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Bynon by changing the folding direction from folding from inside to outside to instead by folding from outside to inside, as taught by Amplatz, because it would prevent a fold getting caught on the vessel wall ([0042]).
Claim 2 is are rejected under 35 U.S.C. 103 as being unpatentable over Bynon (WO 9633672 A1) in view of Amplatz (US 20090210048 A1) and Rucker (US 20110093002 A1).
Regarding claim 2, Bynon is silent to the stent diameters, however Rucker teaches a multi stent system ([0036]) in that a more inwardly arranged stents ([0036], inner stent) have a diameter of at least the same size as a more outwardly arranged stents ([0036], outer stent), wherein the more inwardly arranged stents ([0036], inner stent) preferably have a larger diameter than the more outwardly arranged stents ([0036], outer stent).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Bynon by including the stent sizing, as taught by Rucker, in order to ensure “an adequate fit between the stents” ([0035]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Bynon (WO 9633672 A1) in view of Amplatz (US 20090210048 A1) and in further view of Pavcnik (US 20010041928 A1), Lecdergerber (US 20040116999 A1), and Walzman (US 20190151072 A1).
Regarding claim 5, Bynon is silent to the cover length, however Pavcnik teaches a covered stent (abstract) that the at least one membrane (covering 14, [0018]) is more than twice as long as the stent (claim 10, “about equal to twice the length” encompasses slightly more than twice as long) on which it is arranged wherein the cover ends overlaps itself (if the cover is folded over and longer than twice the length it overlaps).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Bynon by including the cover sizing, as taught by Pavcnik, in order to prevent flow between the layers ([0018]).
Bynon is silent to the cover length, however Lecdergerber teaches a covered stent ([0089]) wherein one membrane (covering 140, [0089]) is more than twice as long as the stent ([0089]) on which it is arranged wherein the cover ends overlaps itself (if the cover is folded over and longer than twice the length it overlaps).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Bynon by including the cover sizing, as taught by Lecdergerber, in order to secure the cover to the stent ([0083]).
Bynon fails to teach wherein the cover ends overlaps itself. Waltzman teaches a covered stent (abstract) wherein membrane ends (abstract) overlap each other (abstract). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Bynon by including the overlap in the cover, as taught by Waltzman, in order to reduce permeability and improve conformity (abstract, [0036]).
Bynon does not exactly teach the folding direction as claimed. Amplatz teaches a covered stent device ([0042]) wherein a membrane is folded towards an inside of a stent ([0042]). Modifying the in-to-out folding direction with the out-to-in folding direction teaches a stent wherein membrane is arranged on the outside of the second stent and wherein respective membrane ends are folded around respective ends of a stent on which they are arranged, in such a way that the respective membrane ends are guided between the first and the second stent (membrane 16 in figure 5 would be placed on the outside of stent 20 and folded to the inside of stent 20, the ends would be between stent 20 and 18).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Bynon by changing the folding direction from folding from inside to outside to instead by folding from outside to inside, as taught by Amplatz, because it would prevent a fold getting caught on the vessel wall ([0042]).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Bynon (WO 9633672 A1) in view of Amplatz (US 20090210048 A1) and Pavcnik (US 20010041928 A1).
Regarding claim 7, Bynon further teaches two coaxially arranged stents (element 18 and 20. Fig 5) with the first stent (element 18) being positioned on the inside (element 18) and the second stent (element 20) being positioned on the outside (element 20), and the membrane (element 16, fig 5) is arranged on the outside of the second stent (element 16 in fig 5 is on the outside of stent 20) and the membrane of the second membrane (pg 16-17, fig 5 description) are folded over to the inside of the second stent (pg 16-17, fig 5 description).
Bynon does not exactly teach the folding direction as claimed. Amplatz teaches a covered stent device ([0042]) wherein a membrane is folded towards an inside of a stent ([0042]). Modifying the in-to-out folding direction with the out-to-in folding direction teaches a stent wherein the membrane ends are folded over onto the inside of the second stent so that the membrane is are clamped in place between the (membrane 16 in figure 5 would be placed on the outside of stent 20 and folded to the inside of stent 20, the ends would be between stent 20 and 18).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Bynon by changing the folding direction from folding from inside to outside to instead by folding from outside to inside, as taught by Amplatz, because it would prevent a fold getting caught on the vessel wall ([0042]).
Bynon fails to teach a second membranes on the inner stent. Pavcnik teaches a covered stent (abstract) wherein a membrane (tube 24 [0018]) is arranged on the inside of the first stent ([0018]) and the membrane ends ([0018]) of the membrane are folded over to the outside of the first stent ([0018]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Bynon by including an inner stent membrane, as taught by Pavcnik, in order to further prevent flow between the stent layers ([0018]).
Regarding claim 8, Bynon further teaches comprising two coaxially arranged stents (element 18 and 20. Fig 5) wherein the first stent (element 18) is positioned on the inside (element 18) and the second stent (element 20) is positioned on the outside (element 20).
Bynon does not exactly teach the folding direction as claimed. Amplatz teaches a covered stent device ([0042]) wherein a membrane is folded towards an inside of a stent ([0042]). Modifying the in-to-out folding direction with the out-to-in folding direction teaches a stent wherein the membrane ends are folded over onto the inside of the second stent so that the membrane is are clamped in place between the (membrane 16 in figure 5 would be placed on the outside of stent 20 and folded to the inside of stent 20, the ends would be between stent 20 and 18).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Bynon by changing the folding direction from folding from inside to outside to instead by folding from outside to inside, as taught by Amplatz, because it would prevent a fold getting caught on the vessel wall ([0042]).
Bynon fails to teach a membrane on the inner stent. Pavcnik teaches a covered stent (abstract) wherein a membrane (tube 24 [0018]) is arranged on the inside of the first stent ([0018]) and the membrane ends ([0018]) of the membrane are folded over to the outside of the first stent ([0018]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Bynon by including an inner stent membrane, as taught by Pavcnik, in order to prevent flow between the stent layers ([0018]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Bynon (WO 9633672 A1) in view of Amplatz (US 20090210048 A1) and in further view of Pavcnik (US 20010041928 A1) and Rucker (US 20110093002 A1).
Regarding claim 10, Bynon teaches wherein the first stent being arranged on the inside (element 18), the second stent being provided on the outside (element 20), and the outer membrane stent cover/orientation (element 16 in fig 5 is on the outside of stent 20).
Byron fails to teach three coaxially arranged stents and the full three stent membrane arrangement.
Rucker teaches a multi stent system (abstract) wherein there is three coaxially arranged stents (abstract “one or more stents at least partially fill the openings of the outer stent”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Bynon in view of Pavcnik by including an additional stent, as taught by Rucker, between the already existing stents and membrane configuration, in order to further dilate a narrowed portion of the body ([0001-0002]).
Pavcnik teaches a covered stent (abstract) with the inner cover/orientation ([0018]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Bynon by including the inner stent membrane, as taught by Pavcnik, in order to prevent flow between the stent layers ([0018], this inner membrane would be folded between the inner and center stent).
Bynon does not exactly teach the folding direction of the outer stent as claimed. Amplatz teaches a covered stent device ([0042]) wherein a membrane is folded towards an inside of a stent ([0042]). Modifying the in-to-out folding direction with the out-to-in folding direction teaches a stent wherein membrane is arranged on the outside of the second stent and wherein respective membrane ends are folded around respective ends of a stent on which they are arranged, in such a way that the respective membrane ends are guided between the first and the third stent (membrane 16 in figure 5 would be placed on the outside of stent 20 and folded to the inside of stent 20, the ends would be between the outer and middle stent).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Bynon by changing the folding direction from folding from inside to outside to instead by folding from outside to inside, as taught by Amplatz, because it would prevent a fold getting caught on the vessel wall ([0042]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Bynon (WO 9633672 A1) in view of Amplatz (US 20090210048 A1) and Chuter (US 8211166 B2).
Regarding claim 13, Bynon further teaches wherein the retaining elements (element 21, fig 1) are to be of hook-shaped configuration (barbs are hook-shaped).
Bynon fails to teach wherein the retaining elements extend outward. Chuter teaches a stent device (col 1, lines 34-37) with hook retaining features (element 46, fig 1) directed radially outward (col 3. Lines 33-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Bynon by including outward features, as taught by Chuter, in order to attach to the target wall (col 3. Lines 33-45).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANNA LOUISE PASQUALINI whose telephone number is (703)756-1984. The examiner can normally be reached Telework 7:30PM-5:00PM EST M-F (occasionally off Fridays).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/H.L.P./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799